(87 days)
Not Found
No
The device is a physical examination glove and the summary describes testing related to material properties and chemical resistance, with no mention of AI or ML.
No
The device, "Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs)", is intended to prevent contamination between patient and examiner, not to provide therapy or treatment for a disease or condition.
No
This device is described as a glove intended to prevent contamination between patient and examiner, not to diagnose any condition.
No
The device is a physical product (gloves) and does not involve any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
- Device Description: The description reinforces the barrier function and mentions testing for chemotherapy drug permeation, which is a safety feature, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
- Performance Studies: The performance studies focus on physical properties, safety (biocompatibility, chemotherapy permeation), and freedom from defects, which are relevant to a medical glove, not an IVD. Key metrics mentioned are related to these physical and chemical properties, not diagnostic accuracy (like sensitivity, specificity, etc.).
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not perform any of these functions.
N/A
Intended Use / Indications for Use
Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs) is a non-sterile, single-use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, OPJ
Device Description
The subject device, Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs), is a single use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. These gloves are made of synthetic copolymer of acrylonitrile and butadiene with a blue color additive. The gloves are provided in sizes XS, S. M, L and XL.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Tests Performed:
Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs) was tested and found in conformance with the following standards:
-
ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application:
- Requirements: Product dimension pass (between the tolerance gaps), Width: 70 mm (±10mm) - XS, 80 mm (±10mm) - S, 95 mm (±10mm) - M, 110 mm (±10mm) - L, 120 mm (±10mm) - XL, Overall Length: 220 mm (Minimum) – S and XS, 230 mm (Minimum) – M, L and XL, Thickness: (for all sizes) Finger -0.05 mm (Minimum), Palm -0.05mm (Minimum).
- Results: Pass.
-
ASTM D412-16 Standards test method for Vulcanized Rubber and Thermoplastics Elastomer - Tension:
- Requirements: Physical properties: Before Aging: Tensile strength: min 14MPa, Elongation: min 500%; After Aging: Tensile strength: min 14MPa, Elongation: min 400%.
- Results: Pass.
-
ASTM D5151-19 Standard Test Method for detection of Holes in Medical Gloves:
- Requirements: Pass Inspection Level G1, AQL 2.5.
- Results: Pass.
-
ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves:
- Requirements: Residual powder meets specification
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
August 5, 2022
Rubberex Alliance Products Sdn Bhd % Kewin Tham Official Correspondent Mdi Consultants, Inc. 55 Northern Blvd. Suite 200 Great Neck, New York 11021
Re: K221350
Trade/Device Name: Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ Dated: May 9, 2022 Received: May 10, 2022
Dear Kewin Tham:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221350
Device Name
Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
Indications for Use (Describe)
Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs) is a non-sterile, singleuse, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves have been
tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
List of Drugs tested concentration and breakthrough detection time in maximum testing time is 240 minutes.
| Drug Tested | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/mL (3300 ppm) | 14.6 |
| Cisplatin | 1.0 mg/mL (1000 ppm) | > 240 |
| Cyclophosphamide (Cytoxan®) | 20 mg/mL (20000 ppm) | > 240 |
| Dacarbazine (DTCI) | 10 mg/mL (10000 ppm) | > 240 |
| Doxorubicin Hydrochloride | 2.0 mg/mL (2000 ppm) | > 240 |
| Etoposide (ToposarⓇ) | 20 mg/mL (20000 ppm) | > 240 |
| Fluorouracil | 50 mg/mL (50000 ppm) | > 240 |
| Paclitaxel (Taxol®) | 6.0 mg/mL (6000 ppm) | > 240 |
| Thiotepa | 10 mg/mL (10000 ppm) | 15.0 |
Warning: Do not use with Carmustine and Thiotepa.
Please note that the following drugs have low permeation times:
| Camustine (BCNU) | 3.3 mg/mL (3300 ppm) | 14.6 minutes |
|---|---|---|
| Thiotepa | 10.0 mg/mL (10000 ppm) | 15.0 minutes |
Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☑ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(k) SUMMARY
K221350 Date Summary Prepared: 29 July 2022
1. Submitter's Identification:
| a. Applicant: | RUBBEREX ALLIANCE SDN BHD
Lot 138201 Off ¾ Mile, Jalan Bercham
Kawasan Perindustrian Bercham
31400 Ipoh, Perak, Malaysia |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| b. Applicant Contact Person: | Sabri Bin Abdul Hamid
Lot 138201 Off ¾ Mile, Jalan Bercham
Kawasan Perindustrian Bercham
31400 Ipoh, Perak, Malaysia |
| c. Official 510k Correspondent: | Ms. Kewin Tham
Official Contact for RUBBEREX ALLIANCE SDN BHD |
| d. Official 510k Correspondent Firm | Mdi Consultants, Inc
55 Northern Blvd. Suite 200
Great Neck, New York 11021
(516) 482-9001
Fax: (516) 482-0186
Email: kewin@mdiconsultants.com |
2. Name of the Device:
Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
| Regulation Number: | 21 CFR 880.6250 |
|---|---|
| Regulation Name: | Non-Powdered Patient Examination Glove |
| Regulatory Class: | Class I, reserved |
| Product Code: | LZA, LZC, OPJ |
3. Information for the 510(k) Cleared Device (Predicate Device):
| Predicate device: | K213227 |
|---|---|
| Trade/Device Name: | Uweport Powder-Free Nitrile Examination Gloves Tested for Use |
| with Chemotherapy Drugs | |
| Device Classification Name: | Non-Powdered Patient Examination gloves |
| Regulation Number: | 21 CFR 880.6250 |
| Device Class: | Class I |
| Product Code: | LZA, LZC, OPJ |
| Applicant name: | Uweport LLC. |
4. Device Description:
The subject device, Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs), is a single use, disposable device intended for medical purposes that is worn
5
on the examiner's hand to prevent contamination between patient and examiner. These gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. These gloves are made of synthetic copolymer of acrylonitrile and butadiene with a blue color additive. The gloves are provided in sizes XS, S. M, L and XL.
ട. Indications for Use:
Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs) is a non-sterile, single-use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
List of Drugs tested concentration and breakthrough detection time in minutes. The maximum testing time is 240 minutes.
| Drug Tested | Concentration | Breakthrough
Detection Time
in Minutes |
|-----------------------------|----------------------|----------------------------------------------|
| Carmustine (BCNU) | 3.3 mg/mL (3300 ppm) | 14.6 |
| Cisplatin | 1.0 mg/mL (1000 ppm) | > 240 |
| Cyclophosphamide (Cytoxan®) | 20 mg/mL (20000 ppm) | > 240 |
| Dacarbazine (DTCI) | 10 mg/mL (10000 ppm) | > 240 |
| Doxorubicin Hydrochloride | 2.0 mg/mL (2000 ppm) | > 240 |
| Etoposide (Toposar®) | 20 mg/mL (20000 ppm) | > 240 |
| Fluorouracil | 50 mg/mL (50000 ppm) | > 240 |
| Paclitaxel (Taxol®) | 6.0 mg/mL (6000 ppm) | > 240 |
| Thiotepa | 10 mg/mL (10000 ppm) | 15.0 |
Warning: Do not use with Carmustine and Thiotepa.
| Please note that the following drugs have low permeation times: | ||
|---|---|---|
| Camustine (BCNU) | 3.3 mg/mL (3300 ppm) | 14.6 minutes |
| Thiotepa | 10.0 mg/mL (10000 ppm) | 15.0 minutes |
6. Comparison to the 510(k) Cleared Devices (Predicate Devices):
Table 1: Comparison to Predicate Device
| Characteristic | Predicate Device | Subject Device | Comparison
Analysis |
|--------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Manufacturer | Uweport LLC | Rubberex Alliance Sdn
Bhd | N/A |
| Device Name | Nitrile Exam Glove (tested
for use with Chemotherapy
Drugs) | Non-sterile Powder Free
Nitrile Examination Gloves
(tested for use with
Chemotherapy Drugs) | Similar |
| 510(k) Reference | K213227 | K221350 | N/A |
| Product Code | LZA, LZC, OPJ | LZA, LZC, OPJ | Same |
| Characteristic | Predicate Device | Subject Device | Comparison
Analysis |
| Indication for Use | Uweport Powder-Free
Nitrile Exam Gloves Tested
for Use with Chemotherapy
Drugs is a non-sterile,
disposable device intended
for medical purposes that is
worn on the examiner's
hand to prevent
contamination. The Gloves
have been tested for use
with chemotherapy drugs
per ASTM D6978-05(2019)
Standard Practice for
Assessment of Resistance of
Medical Gloves to
Permeation by
Chemotherapy Drugs. | Non-sterile Powder Free
Nitrile Examination Gloves
(Tested for Use with
Chemotherapy Drugs) is a
non-sterile, disposable
device intended for
medical purposes that is
worn on the examiner's
hand to prevent
contamination. The gloves
have been tested for use
with chemotherapy drugs
per ASTM D6978-
05(2019) Standard Practice
for Assessment of
Resistance of Medical
Gloves to Permeation by
Chemotherapy Drugs. | Similar |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Material | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| Design Features | Ambidextrous
Textured fingertips
Beaded cuff
Straight fingers | Ambidextrous
Textured fingertips
Beaded cuff
Straight fingers | Same |
| Sizes | Small, Medium, Large,
Extra Large | Extra Small, Small,
Medium, Large, Extra
Large | Different
(1) See Below |
| Dimension-Thickness | Complies with ASTM
D6319-19
Palm: 0.07S; 0.08M; 0.08L;
0.08XL all ± 0.03mm
Finger: 0.09 ± 0.03mm | Complies with ASTM
D6319-19
Palm: min 0.05mm
Finger: min 0.05mm | Different
See Below
(2) |
| Dimension-Width | Complies with ASTM
D6319-19
Small: 85 ± 5mm
Medium: 96 ± 5mm
Large: 108 ± 5mm
Extra Large: 115 ± 5mm | Complies with ASTM
D6319-19
Extra Small: 70 ± 10mm
Small: 80 ± 10mm
Medium: 95 ± 10mm
Large: 110 ± 10mm
Extra Large: 120 ± 10mm | Different
See Below
(3) |
| Dimension-Length | Complies with ASTM
D6319-19
Small: ≥ 220mm
Medium/Large/Extra Large:
≥ 240mm | Complies with ASTM
D6319-19
Extra Small/Small: ≥
220mm
Medium/Large/Extra
Large: ≥ 230mm | Different
See Below
(4) |
| Rx vs OTC | OTC | OTC | Same |
| Sterile vs Non-Sterile
Disposable vs Non-
Disposable | Non-Sterile
Disposable | Non-Sterile
Disposable | Same
Same |
| Biocompatibility
Cytotoxicity ISO
10993-5 | At 100% extraction the cell
viability was 17.1%. | Exhibited "Severe"
reactivity at 100%
concentration and no | Different
See Below
(5) |
| Characteristic | Predicate Device | Subject Device | Comparison
Analysis |
| Biocompatibility
Sensitization ISO
10993-10 | The test article passed both
extracts with a 0 score. | The test article passed both
extracts with a 0 score. | Same |
| Biocompatibility
Irritation ISO 10993-10 | The test article from both
extracts was categorized as
negligible under the test
conditions. | The test article from both
extracts was categorized as
negligible under the test
conditions. | Same |
| Biocompatibility
Acute Systemic
Toxicity ISO 10993-11:2017 | Under the conditions of the
study the test article extract
met the requirements of the
study; Body weight data and
animal appearance was
normal throughout the study. | Under the conditions of the
study the test article extract
met the requirements of the
study; Body weight data
and animal appearance was
normal throughout the
study. | Same |
| Single Use | Yes | Yes | Same |
| Physical Properties -
Tensile Strength | Complies with ASTM
D6319-19 at nominal
conditions ≥ 14MPa | Complies with ASTM
D6319-19 at nominal
conditions ≥ 14MPa | Same |
| Physical Properties -
Elongation | Complies with ASTM
D6319-19 at nominal
conditions; ≥ 500% | Complies with ASTM
D6319-19
Before aging: min 500%
After aging: min 400% | Different
(6) See Below |
| Freedom from Holes | Complies with ASTM
D5151-19; AQL = 2.5, 125
samples from batch of
35000, inspection level 1,
criterion ≤ 7
Zero nonconforming | Complies with ASTM
D5151-19; AQL = 2.5,
Inspection level G-1 | Similar |
| Residual Powder | ASTM D6124 Standard Test
Method for Residual Powder
on Medical Gloves; residual
powder 0.15; 0.18 and 0.19
mg/ glove | Complies with ASTM
D6124 Standard Test
Method for Residual
Powder on Medical
Gloves; residual powder ≤
2.0 mg/ glove | Similar |
| Chemotherapy
Permeation
ASTM D6978-
05(2019) Assessment
of Resistance of
Medical Gloves to
Permeation by
Chemotherapy Drugs | Carmustine (BCNU) 3.3
mg/mL (3300 ppm): 22.6
minutes | Carmustine (BCNU) 3.3
mg/mL (3300 ppm): 14.6
minutes | Similar |
| | Cisplatin 1.0 mg/mL (1000
ppm): > 240 minutes | Cisplatin 1.0 mg/mL (1000
ppm): > 240 minutes | Same |
| | Cyclophosphamide
(Cytoxan®) 20 mg/mL
(20000 ppm): > 240 minutes | Cyclophosphamide
(Cytoxan®) 20 mg/mL
(20000 ppm): > 240
minutes | Same |
| | Dacarbazine (DTIC) 10
mg/mL (10000 ppm): > 240
minutes | Dacarbazine (DTIC) 10
mg/mL (10000 ppm): >
240 minutes | Same |
| | Doxurubicin Hydrochloride
2.0 mg/mL (2000 ppm): >
240 minutes | Doxurubicin
Hydrochloride 2.0 mg/mL
(2000 ppm): > 240 minutes | Same |
| Characteristic | Predicate Device | Subject Device | Comparison
Analysis |
| | Etoposide (Toposar®) 20
mg/mL (20000 ppm): > 240
minutes | Etoposide (Toposar®) 20
mg/mL (20000 ppm): >
240 minutes | Same |
| | Fluorouracil 50 mg/mL
(50000 ppm): > 240 minutes | Fluorouracil 50 mg/mL
(50000 ppm): > 240
minutes | Same |
| | Paclitaxel (Taxol®) 6.0
mg/mL (6000 ppm): > 240
minutes | Paclitaxel (Taxol®) 6.0
mg/mL (6000 ppm): > 240
minutes | Same |
| | Thiotepa 10 mg/mL (10000
ppm): 46.8 minutes | Thiotepa 10 mg/mL
(10000 ppm): 15.0 minutes | Similar |
6
7
8
1. Sizes
The subject device sizes ranges from Extra Small, Small, Medium, Large, Extra Large, whereas the predicate device size ranges from Small, Medium, Large, Extra Large. This does not introduce any new risk to the device.
2. Dimension-Thickness
The subject device dimension thickness Palm: measures at a min of 0.05mm and Finger: measures at a min of 0.05mm, whereas the predicate device Palm: measures at 0.07 Small; 0.08 Medium; 0.08 Large; 0.08 Extra Large all ± 0.03m and Finger measures at: 0.09 ± 0.03mm. These differences do not affect the performance nor introduce any new risk to the device.
3. Dimension-Width
The subject device which complies with ASTM D6319-19 measures for: Extra Small: 70 ± 10mm Small: 80 ± 10mm Medium: 95 ± 10mm Large: 110 ± 10mm Extra Large: 120 ± 10mm Whereas, the predicate device which complies with ASTM D6319-19 measures for: Small: 85 ± 5mm Medium: 96 ± 5mm Large: 108 ± 5mm Extra Large: 115 ± 5mm These differences do not affect the device's performance or safety and effectiveness.
4. Dimension-Length
The subject device which complies with ASTM D6319-19 measures for: Extra Small/Small: ≥ 220mm Medium/Large/Extra Large: ≥ 230mm Whereas, the predicate which complies with ASTM D6319-19 measures for: Small: ≥ 220mm Medium/Large/Extra Large: ≥ 240mm
9
These dimensional differences does not introduce any new risk to the device. Nor does it affect the device's safety and effectiveness.
5. Biocompatibility- Cytotoxicity ISO 10993-5
The subject device exhibited "severe" reactivity at 100% concentration and no cytotoxic effect at 10% concentration. Whereas, for the predicate device, at 100% extraction the cell viability was 17.1%.. To demonstrate the safety of the materials the sponsor elected to perform a systemic toxicity study in which the device was found to be non-toxic.
6. Physical Properties - Elongation
The subject device which complies with ASTM D6319-19 was found to be Before aging: min 500% After aging: min 400% Whereas, the predicate device which complies with ASTM D6319-19 at nominal conditions was ≥ 500%
These differences do not affect the device's performance or safety and effectiveness.
7. Summary of Non-Clinical Tests Performed
Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs) was tested and found in conformance with the following standards.
| Standard | Testing | Requirements | Results |
|---|---|---|---|
| ASTM D6319-19 | Standard Specification | ||
| for Nitrile | |||
| Examination Gloves | |||
| for Medical | |||
| Application | Product dimension pass (between the | ||
| tolerance gaps) | Pass | ||
| Width: | |||
| 70 mm (±10mm) - XS | |||
| 80 mm (±10mm) - S | |||
| 95 mm (±10mm) - M | |||
| 110 mm (±10mm) - L | |||
| 120 mm (±10mm) - XL | |||
| Overall Length: | |||
| 220 mm (Minimum) – S and XS | |||
| 230 mm (Minimum) – M, L and | |||
| XL | |||
| Thickness: (for all sizes) | |||
| Finger -0.05 mm (Minimum) | |||
| Palm -0.05mm (Minimum) | |||
| ASTM D412-16 | Standards test method | ||
| for Vulcanized Rubber | |||
| and Thermoplastics | |||
| Elastomer - Tension | Physical properties: | ||
| Before Aging: | |||
| Tensile strength: min 14MPa | |||
| Elongation: min 500% | Pass | ||
| After Aging: | |||
| Tensile strength: min 14MPa |
Table 2: Summary Non-Clinical Tests
10
| Standard | Testing | Requirements | Results |
|---|---|---|---|
| Elongation: min 400% | |||
| ASTM D5151-19 | Standard Test Method | ||
| for detection of Holes | |||
| in Medical Gloves | Pass Inspection Level G1, AQL 2.5 | Pass | |
| ASTM D6124-06 | Standard Test Method | ||
| for Residual Powder | |||
| on Medical Gloves | Residual powder meets specification |